Drugs & medicalClass II

Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog…

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

Read the official notice →
Date
2024-04-03
Country
United States
Brand
Randox Laboratories
Product
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog…
Classification
Class II
Units
US Nationwide distribution in the states of CA, IN.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Randox Laboratories recalls

  1. 2024-05-15
  2. US
    Drugs & medicalClass III

    Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of…

    Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used…

    Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

    FDA · DeviceRandox Laboratories Ltd.Domestic: Nationwide Distribution.Official notice →
  4. 2024-04-24
  5. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

    Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, MA, WV including PR.Official notice →
  6. 2024-03-27
  7. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample…

    The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

    FDA · DeviceRandox Laboratories Ltd.Domestic: CA, FL, IL, ME, NJ, OH, & OR.Official notice →
  8. 2024-02-14
  9. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340

    Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of SC and OK.Official notice →
  10. 2024-01-24
  11. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

    Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

    FDA · DeviceRandox Laboratories Ltd.US Nationwide including Puerto Rico.Official notice →
All 27 Randox Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2024-04-03
  2. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I

    The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing…

    FDA · DeviceOrtho-Clinical DiagnosticsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  3. US
    Drugs & medicalClass II

    Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter…

    Use of assay along with plasma specimen may result in error code which would invalidate sample.

    FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL,…Official notice →
  4. US
    Drugs & medicalClass II

    Alcon Research, LLC recalls SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44,…

    Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so…

    FDA · DeviceAlcon Research, LLCUS Nationwide distribution in the states of OH, WV.Official notice →
  5. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model…

    Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be…

    FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice →
  6. US
    Drugs & medicalClass II

    Bruder Healthcare Company, LLC recalls Thermalon Stye Compress, Item Number 24352

    Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

    FDA · DeviceBruder Healthcare Company, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice →
  7. US
    Drugs & medicalClass II

    Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

    FDA · DeviceBio-Rad LaboratoriesUS Nationwide distribution in the states of PA, SD, TX, FL, MN.Official notice →
See all drugs & medical recalls →